FDA: Approves CucciYuZumab (Can Be Good) Treatment for Mid-Axis Spinal Arthritis

On June 17, Novartis announced that the U.SFDAhad approved Cosentyx (secukinumab, Cucciyu monotophos) for the treatment of active radiology-negative mid-axis spinal arthritis (nr-axSpA), confirming Cosentyx's efficacy in addressing the spectrum of methaline spinal arthritis (axSpA)The nr-axSpA approval is Cosentyx's fourth indication, and its long-term safety and efficacy are supported by 5 years of clinical data in patients with moderate to severe plaque psyritus (PsO), psoriasis arthritis (PsA) and aggressive spina rhioitis (AS)Cosentyx was approved for nr-axSpA-based efficacy and safety results in a prevent clinical trial, and as early as April this year, thethe European Union approved Novartis' IL-17 monoantitics for the treatment of non-radiation axial spinal arthritisPREVENT is a two-year, randomized, double-blind, placebo-controlled clinical phase 3 study designed to investigate the efficacy and safety of Cosentyx in active nr-axSpA patientsThe main endpoint was the proportion of patients with biopharmaceutical therapy who received a response of 40 (ASAS40) at the 16th and 52nd weeks using 150mg CosentyxThe study involved 555 adult patients with active nr-axSpA (pre-45 age, visual simulation scale (VAS) rated at 40/100 and Bath severe spinal inflammatory disease activity index (BASDAI) plus 4), who received at least two different, highest doses of nonsteroidal anti-inflammatory drugs (NSAID) treatment in the 4 weeks prior to the start of the studyPatients may have previously used TNF inhibitors (no more than one), but the efficacy was poor, with 501 (90%) of the 555 patients selected in the study having not received biological treatmentClinical trial results showed that Cosentyx reached the primary endpoint compared to placebo, achieved a statistically significant improvement in the signs and symptoms of nr-axSpA, and at least 40 percent improvement in ASAS40 responses in patients with primary biological treatment at the 52st weekSee more:Novartis III PREVENT Study: IL-17A Single Anti-Cosentyx Can Persist Intheavesal Remissionother related studies:Novartis Single Anti-secukumab Aggressive Spinab III Clinical Success, and NEJM: Secukinab Can Significantly Improve Active Period Strong Spinab
symptoms "The results from the PREVENT clinical trial show a significant reduction in disease activity in patients treated with Cosentyx compared to placebos, and this approval brings a new treatment option for patients with radiological-negative mid-axis spinal arthritis (nr-axSpA)," said Dr Atul Deodhar, professor of medicine at Oregon Health and Science Stakes, medical director of the Rheumatism Clinic, and a researcher on the prevent trial Cassie Shafer, chief executive of the American Association of Spina Bifitis (SAA), said: "There is an urgent need for an additional treatment option, and it is encouraging that Cosentyx is offering a new treatment option for the axSpA patient population Helping to reduce the burden on patients with radiological-negative midaxaarthritis by improving the symptoms of daily life remains a key concern for SAA "
nr-axSpA is part of the spectrum of disease saclistic spinal arthritis (axSpA), which affects about 2.7 million people in the United States and still is grossly undervalued axSpA is a long-term inflammatory disease characterized by chronic inflammatory back pain AxSpA includes AS and nr-axSpA, where joint damage is commonly visible in x-line examination, and joint damage in nr-axSpA patients is not visible in x-line examination Some of the symptoms of the two disease spectrums bear a similar burden, including pain caused by waking up at night, spinal pain, morning stiffness, fatigue, and dysfunction If left untreated, axSpA can impair activity, result in loss of working hours, and have a significant impact on quality of life, including family relationships Cosentyx is the first and only all-human biologic that directly inhibits interleukin-17A (IL-17A), and IL-17A is an important cytokine involved in the development of psoriasis arthritis (PsA), moderate to severe plaque psoriasis (PsO), aggressive spina encephalitis (AS) and nr-axSpA inflammation and development Cosentyx has been a clinical study for more than 13 years The drug is supported by strong investigative evidence, including 5 years of clinical data supporting long-term safety and efficacy in moderate to severe plaque psyllite (PsO), psoriasis arthritis (PsA), and aggressive spina bifida (AS) These data reinforce Cosentyx's unique position as a comprehensive treatment for mid-axis spinal arthritis, psoriasis arthritis and psoriasis, with more than 340,000 patients worldwide treated since its launch in China, Cosentyx (Chinese commodity name: Good, generic name: Skuchiyu monotonica) has been approved for the treatment of moderate to severe plaque psoriasis (PsO) adult patients with systemic treatment or phototherapy indications and adult patients with severe spinal scoliosis (AS) with poor efficacy in conventional treatments It is worth mentioning that yesterday, Novartis Pharmaceuticals (China) announced that it can be comfortable with the approval of the pen in China As an upgraded version of the pre-filled needle, can be good self-felt with the pen will optimize the original way of administration, "one-touch" operation to reduce the difficulty of injection, improve the patient's treatment experience, while effectively avoiding the drug waste caused by operational errors, for the vast number of patients with moderate to severe plaque psoriasis and patients with strong scoliosis to bring more convenient, safe and efficient treatment of new experience In April 2019, Novartis' IL-17 Single Anti Cosentyx was approved for domestic listing
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